Kornimate/medical-research-clean huggingface dataset:
parent-supported social skills training for teens with autism spectrum disorders (peers-k)

Conditions: Autism Spectrum Disorders

Summary: this study aims to develop a parent-assisted social skills training program for adolescents with autism spectrum disorder(asd) and verify therapeutic effects of the program through case-control study. 1. both the case and the control of this study shall be a high-functioning group consisting of adolescents aged 11 to 18 years with asd and an iq of 80 or over. a total of 40 adolescents will be recruited and divided into two groups of twenty. one will be the case group and the other will be the waitlist control group. again, the case will be divided into two sub-groups of ten and carry out this new developed program for both parents and adolescents. that is, the program will be carried out two times in each of both groups. the waitlist control group will be allowed to receive personal outpatient treatment and general therapeutic intervention from community while waiting. 2. effects of the program will be measured both at the case and the control by using a scale which measures social interaction, quality of peer relationship, disposition of autism and social anxiety. equal assessments for both the case and the control will be conducted right before the beginning of the program and right after the completion of the program and some of the survey will be retried in order to see mid- and long-term effects three months after the completion of the program.


Eligibility criteria:
inclusion criteria: * 11 to 18 years with asd and an iq of 65 or over exclusion criteria: * adolescents who are hard to understand the content of treatment and carry out the task due to their iqs or limited linguistic abilities * adolescents who are uncooperative in the treatment, lack motives and are hard to participate voluntarily * adolescents who have behavior problems so clinically significant that they affects the therapeutic procedure or problems in controlling their emotion
testing of an electronic patch during mild dehydration

Conditions: Dehydration

Summary: the purpose of this study is to investigate the ability of a wearable bioimpedance sensor to detect mild dehydration in healthy volunteers following the administration of furosemide. in addition, the study will investigate changes in bioimpedance related to normal variation in tissue hydration (circadian changes, skin thickness, posture, and moderate activity). the study will also provide information on the durability of the sensor.

the subjects will use the patches for ten days. during the ten-day period, subjects are exposed to an intervention on day 2 or 3 while being monitored by health personnel: * subjects are given a diuretic (furosemide) and monitored for two hours without any intake. * the intervention is followed by intake of a rehydration solution (up to 1500 ml), containing glucose and electrolytes (resorb sport, nestle s.a.).

Eligibility criteria:
inclusion criteria: * bmi: 18-30 * age: 18-60 * willing to refrain from exercise for the duration of the study * willing to refrain from bathing, swimming and other physical activity causing considerable sweating/movement (e.g. cycling, mountain hiking, climbing) exclusion criteria: * hypersensitivity to diuretics * diarrhea * hypotension or orthostatic hypotension * urinary retention * pregnancy or breast feeding * allergy to medical adhesive or gel * any planned medical examination during the intervention period * pacemaker * use of medication with a significant impact on the body's fluid balance, such as diuretic

Keywords: dehydration rehydration
treatment of diabetic macular edema with 0.5mg intraocular ranibizumab (lucentis)

Conditions: Age-Related Macular Degeneration

Summary: in this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (dme) under the influence of lucentis. measurements with the multifocal electroretinogram (erg) and microperimetry is used here as an objective criteria to information about the retinal function obtain.


Eligibility criteria:
inclusion criteria: 1. diabetic macular edema with center involvement in at least one eye 2. patients with a central retinal thickness 3. patients with a bcva of 78-24 edtrs letters 4. decrease in vision is due to dme and not due to other causes, in the opinion of the investigator 5. type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening exclusion criteria: 1. history or evidence of severe cardiac disease 2. clinical or medical history uncontrolled hypertension or diabetes 3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months 4. ventricular tachyarrhythmias requiring ongoing treatment 5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation 6. clinically significant impaired renal or hepatic function
effect of ezetimibe or simvastatin or both on low densitiy lipoprotein -subfractions in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2; Hypercholesterolemia

Summary: it is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense low density lipoprotein (dldl) in patients with type 2 diabetes mellitus. the primary objective of this study will be whether there is a change of the concentrations of apolipoprotein b (apob) in dldl from baseline in each of the 3 treatment groups.

the selective cholesterol resorption inhibitor ezetimibe belongs to a new class of cholesterol lowering drugs. it is of interest how ezetimibe alone or in combination with statin may influence atherogenic dense low density lipoprotein (dldl) in patients with type 2 diabetes mellitus. the primary objective of this study will be whether there is a change of the concentrations of apolipoprotein b (apob) in dldl from baseline in each of the 3 treatment groups. the comparison between treatment groups is exploratory due to insufficient power to detect any change between treatments.

Eligibility criteria:
inclusion criteria: * men \> 18 and ≤ 75 years * post-menopausal women ≤ 75 years (follicle stimulating hormone (fsh) \>30 miu/ml, women \> 60 years fsh \> 20 miu/ml ) * well controlled diabetes mellitus type ii (glycohaemoglobin ≤ 8,0 %) * ldl-cholesterol ≤ 160 mg/dl * ldl-subfractions: concentration of apob-100 in dldl (ldl-5 und ldl-6) \> 25 mg/dl * written informed consent exclusion criteria: * participation in a clinical trial within the last 30 d before screening- visit * patient is unable to give written informed consent * body mass index \ 35 kg/m² * clinical atherosclerotic disease (coronary heart disease, peripheral artery disease, carotid artery disease) * malignoma * uncontrolled arterial hypertension (\>160/\>100 mmhg) * clinically relevant disease of liver and/or kidneys * clinically relevant endocrinally or hematologic problems * allergy to study medication (ezetimibe and/or simvastatin) * alcohol- or drug abuse * laboratory: alanine aminotransferase, aspartate aminotransferase, total bilirubin \> 3 x uln, creatine kinase \> 5 x uln * concurrent treatment with potent cyp3a4-inhibitors (e.g. itraconazole, ketoconazole, hiv-protease-inhibitors, erythromycin, clarithromycin, telithromycin und nefazodone) * other relevant diseases

Keywords: atherogenic lipoprotein cardiovascular disease coronary artery disease type 2 diabetes small, dense ldl
study of vitamin d3 substitution to patients with primary immunodeficiency

Conditions: Primary Immune Deficiency Disorder

Summary: hypothesis: cholecalciferol (vitamin d3) prevent respiratory tract infections in patients with primary immunodeficiency.


Eligibility criteria:
inclusion criteria: * age 18-75 * increased number of respiratory tract infections * at least 42 days of infections during 2008 or 2009 * s-25 oh vitamin d3 \< 250 nm * not planning a pregnancy during the coming year * accepting the use of contraceptives during 1 year exclusion criteria: * continuous antibiotic treatment * hypercalcemia * sarcoidosis * kidney disease * tuberculosis * pregnancy * kidney stone * heart medication (glycosides)
evita: evaluation of vip feature in pacemaker patients

Conditions: Arrhythmia

Summary: the primary efficacy objective of this clinical investigation is to demonstrate that the ventricular intrinsic preference (vip™) feature allows to reduce the medium- and long-term incidence of unnecessary ventricular pacing in patients with intact av conduction.


Eligibility criteria:
inclusion criteria: * patient has an indication for implantation of a dual-chamber pacemaker; * patient is implanted or scheduled to be implanted with a st jude medical victory pacemaker, or newer device with the same study relevant feature. exclusion criteria: * patient has persistent or permanent af/afl; * patient has permanent av block; * patient has a pacemaker replacement; * patient is in nyha class iv; * patient is unable to attend the follow-up visits; * patient is pregnant; * patient is less than 18 years of age

Keywords: patients with intact av conduction
investigating medical research trends in osteoarthritis clinical trials

Conditions: Osteoarthritis

Summary: clinical research participation percentages haven't always been fully representative of a given demographic. the goal is to find out which aspects of a clinical trial may make it more difficult for patients to take part or see it through. the data will be evaluated through different demographic lenses and identify trends that could help improve the experience of future osteoarthritis patients during clinical study.


Eligibility criteria:
inclusion criteria: * aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed. * participant has a diagnosis of osteoarthritis. * willing and able to comply with scheduled visits, treatment schedule, laboratory tests and other requirements of the study. exclusion criteria: * patients with any significant history of non-compliance to medical regimens or with inability to grant a reliable informed consent. * pregnant or lactating woman * known medical condition that, in the investigator's opinion, would increase the risk associated with study participation or study drug(s) administration or interfere with the interpretation of safety results

Keywords: osteoarthritis
the role of intracranial electroencephalography (ieeg) in the localization of epileptogenic zones (ez) and its relationship with prognosis

Conditions: Epilepsy

Summary: the mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. for focal drug-resistant epilepsy, surgical removal of the epileptogenic zone can control seizures, but the overall seizure-free rate in the long term after surgery is 60-70%, and the results are still not satisfactory. accurate assessment of the location and extent of the epileptogenic zone and its adequate excision are prerequisites for the success or failure of surgery. intracranial eeg (ieeg) has been shown to be the most accurate method for determining the location and boundaries of the epileptogenic zone. it can selectively record the local cortical electrical activity through intracranial electrodes and achieve high temporal resolution for long-range recording, reliably reflecting the continuous dynamic changes of eeg during interictal and ictal periods. the in-depth analysis of ieeg can improve the efficacy of epilepsy surgery and provide important information to reveal the pathogenesis of epilepsy.


Eligibility criteria:
inclusion criteria: 1. complete clinical history; 2. ieeg monitoring at least one habitual seizure； 3. follow up for at least 1 year； 4. signed informed consent. exclusion criteria: 1. habitual seizures were not found in ieeg monitoring; 2. no operation was performed; 3. lost to follow-up for various reasons within 1 year after surgery.
nutritional regulation of leukocyte function

Conditions: FPP; Fermented Papaya Preparation; Supplements; Diabetic Wound; Healing Wound

Summary: the objective of the current study is to determine the dose at which fermented papaya preparation ( fpp) is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (pbmc) and neutrophils of participants. our investigators have reported that supplementation with standardized fermented papaya preparation (fpp) in mice improves dermal wound healing outcomes. therefore, based on these observations, the investigators propose to study the dose at which fpp supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.

fermented papaya preparation (fpp) is a dietary supplement that is available as over-the-counter in the us. fpp possesses antioxidant properties, which provide benefit against age-related complications\[\]. chronic wounds in patients with diabetes represent a major public health problem. previous studies from the investigators have demonstrated that wound-site macrophages from patients with diabetes are compromised in their ability to support wound healing. several independent observations convergently point toward the hypothesis that treatment with papaya preparations may facilitate wound healing responses. our laboratory reported the first evidence demonstrating that fpp may improve diabetic wound outcomes by specifically influencing the response of wound-site macrophages and the subsequent angiogenic response. fpp has a long track record of safe human consumption. the objective of the current study is to determine the dose at which fpp is able to improve inducible respiratory burst outcomes in peripheral blood mononuclear cells (pbmc) and neutrophils of participants. our investigators have reported that supplementation with standardized fermented papaya preparation (fpp) in mice improves dermal wound healing outcomes. therefore, based on these observations, the investigators propose to study the dose at which fpp supplementation induces respiratory burst in blood-derived myeloid cells in healthy subjects.

Eligibility criteria:
inclusion criteria: * ages 18 and above * subjects must be able to follow directions and give informed consent on their own exclusion criteria: * • individuals who are deemed unable to understand the procedures, risks and benefits of the study, ie. informed consent will be excluded. * females who are pregnant will also be excluded to minimize the risk to such individuals (and fetus). * individuals who are therapeutically immuno-compromised will also be excluded to decrease statistical variability and to minimize potential of confounders. * candidates for inclusion into the study will not include individuals as defined in 45 cfr 46 subparts b, c and d, nor from any other population which may be considered vulnerable.

Keywords: fermented papaya wound healing responses
a study of the efficacy and safety of anidulafungin vs. fluconazole in the treatment of patients with candidemia and/or other forms of invasive candidiasis

Conditions: Candidemia

Summary: in the treatment of patients with candidemia and/or other forms of invasive candidiasis , anidulafungin is at least as effective and safe as fluconazole.

to support anidulafungin nda in china due to the challenges in subject recruitment resulting in protracted study course, pfizer inc. has decided to terminate trial a8851023 prematurely based on the recommendation by the senior management team on november 8, 2011. the decision to terminate the trial was not based on any safety concerns. all investigators were verbally informed by the study team since november 8, 2011 to stop the subject recruitment as soon as possible. all 17 enrolled subjects have been followed up on safety issues and no safety concerns were present by the data of these subjects.

Eligibility criteria:
inclusion criteria: * presence of candidemia or invasive candidiasis. * presence of one or more of signs and symptoms of acute fungal infection. exclusion criteria: * subjects who received greater than 48 hours of systemic antifungal treatment for the candida infection for which they will be enrolled. * subjects with hypersensitivity to echinocandins or azole therapy or drug excipients.

Keywords: phase 3b efficacy and safety evaluation of anidulafungin icc
hypogastric plexus block and ganglion impar block for cervical and endometrial cancer pain management

Conditions: Cervical Cancer; Endometrial Cancer

Summary: this study compared the efficacy and safety of superior hypogastric plexus block and ganglion impar block procedures on the management of pelvic and perineal cancer pain in patients with cervical and endometrial cancer

superior hypogastric plexus block is a commonly used method for the management of pelvic and perineal pain due to cancer, this procedure uses a transdiscal approach at the level of the l5-s1 vertebrae by injecting 5 ml of 1% lidocaine + 10 ml of 96% alcohol and confirmed by c-arm. compared with the ganglion impar block procedure using a trans-sacrococcygeal approach by injecting 4 ml of 1% lidocaine + 6 ml of 96% alcohol and confirmed by c-arm. the aim of this study was to compare the efficacy and safety of the ganglion impar block procedure against the superior hypogastric plexus block which is commonly used in the management of pelvic and perineal pain due to cervical and endometrial cancer.

Eligibility criteria:
inclusion criteria: * unbearable cancer pain that is resistant to who (world health organization) pain ladder at least 2 weeks medication * the patient is tired of taking medication orally or complications of current medication (respiratory depression, nausea, vomiting, opioid-induced constipation, gastrointestinal disturbances) * patients with pelvic floor pain diagnosed by a (fellow of interventional pain practice) fipp-certified pain specialist * patients with pain in the perineum diagnosed by a fipp-certified pain specialist * numerical rating scale \>4 * \>18 years old * able and willing to sign an informed consent exclusion criteria: * refuse to be included in the research * blood clotting disorders (including taking anticoagulant drugs) * local infection in the area of action * loss to follow up drop-out criteria: * loss to follow up * intervention complications occur * failed intervention

Keywords: perineal pain cervical cancer endometrial cancer superior hypogastric plexus block ganglion impar block pelvic pain
efficacy and safety of ibi110 single agent and in combination with sintilimab in patients with relapsed or refractory diffuse large b cell lymphoma (r/r dlbcl)

Conditions: DLBCL

Summary: the purpose of this study is to determine whether treatment with ibi110 single agent and in combination with sintilimab demonstrates sufficient efficacy/safety in r/r dlbcl.

this is a phase ib, open-label, randomized study to determine the efficacy and safety of treatment with ibi110 single agent and in combination with sintilimab in dlbcl that are relapsed and/or refractory to available standard of care therapies. participants in each cohort are randomly assigned to one of the two arms: ibi110 single agent arm and ibi110 in combination with sintilimab arm. participants received study treatment for a maximum of 2 years, or until disease progression (assessed by investigator per lugano 2014 criteria for malignant lymphoma (cheson et al 2014)), unacceptable toxicity, death or discontinuation from study treatment for any other reason.

Eligibility criteria:
inclusion criteria: * provide signed written informed consent, which includes compliance with the requirements and restrictions listed in the consent form. * male or female, 18-70 years old (at the time consent is obtained) * eastern cooperative oncology group (ecog) performance status of 0 or 1. * histologically confirmed diagnosis of dlbcl in a subject who has been pretreated with at least 2 lines of systematic treatment (regimens containing anthracyclines and anti-cd20 immunotherapy must be included); * subjects whose most recent therapy was car-t cell therapy were also eligible. exclusion criteria: patients previously exposed to any anti-lag-3 treatment. * history of ≥grade 3 crs, neurotoxicity, or hemophagocytic lymphohistiocytosis) during previous car-t cell therapy. * impaired cardiac function or clinically significant cardiac disease. * active, known or suspected autoimmune disease or a documented history of autoimmune disease within two years prior to screening with a few exceptions as per protocol.
safety and efficacy study comparing abt-335 coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with multiple abnormal lipid (fat) levels in the blood

Conditions: Dyslipidemias; Coronary Heart Disease; Combined (Atherogenic) Dyslipidemia; Mixed Dyslipidemia

Summary: the primary purpose of this study is to compare the safety and efficacy of abt-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.


Eligibility criteria:
inclusion criteria: * subjects with mixed dyslipidemia (trigylcerides, \> or = to 150 mg/dl to \ or = to 130 mg/dl). * subjects must agree to use adequate birth control methods and to adhere to the american heart association (aha) diet. exclusion criteria: * subjects with unstable or uncontrolled medical conditions considered inappropriate in a clinical trial. * subjects with an unstable dose of medications or receiving coumadin, oral, intravenous or intramuscular cyclosporine, statins, or certain other medications. * women who are pregnant or plan on becoming pregnant, or women who are lactating.
analgesic effects of the gastrolith, in osteoporotic patients suffering from recent skeletal pain caused by vertebral fractures

Conditions: Osteoporosis

Summary: this study aims to evaluate the safety and analgesic effect (efficacy) of gastrolith powder (gasp) on skeletal pain caused by osteoporotic vertebral compression fractures (ovcf) versus placebo, primarily as assessed by the numeric rating scale (nrs), and brief pain inventory (bpi). it is also intended to evaluate disability change with the oswestry low back pain disability index (odi) and to evaluate whether gasp consumption leads to reduction in analgesic standard of care (asoc) versus placebo, using weekly analgesic consumption diaries.

eighty (80) osteoporotic subjects with recent reported severe back pain caused by ovcf will be blindly randomized into two groups (n=40 each). one group will receive gasp and the other placebo. the analgesic effect of gasp on top of the asoc will be evaluated using weekly nrs and bpi assessments and three odi questionnaires. daily asoc consumption will be monitored using weekly analgesic consumption diaries.

Eligibility criteria:
inclusion criteria: * osteoporotic patients aged 18-80 years old, inclusive. * diagnosed osteoporotic vertebral compression fracture(s) in at least one vertebra caused by an atraumatic event or a minimal traumatic event such as falling from standing height or less, or by other minimal trauma besides a fall (see section 4.2 table i for definitions), and visible by either x-ray radiography, ct or mri. * at least six (6) weeks and no more than six (6) months from the onset of severe back pain suspected to be caused by the ovcf. * presenting a score of ≥5 in the pain nrs during movement (getting up from a chair). * subjects able to adhere to the visit schedule and protocol requirements and be available to complete the study. * subject that had signed the icf. exclusion criteria: * more than six (6) months from the onset of severe back pain suspected to be caused by ovcf.subjects after vertebroplasty or kyphoplasty. * hypercalcemic subjects (calcium \> 10.50 mg/dl). * subjects with renal diseases. * subjects with active malignancy or other active metabolic bone disease which is not osteoporosis. * subjects with cognitive impairments. * pregnant or breastfeeding women.